GSPH Researcher Finds Oversight of Drug Ads Lacking

Spending on direct-to-consumer advertising by the pharmaceutical industry has increased dramatically over the past decade despite a growing chorus of criticism and regulatory actions leveled against it, according to a study being published in the August 16 issue of The New England Journal of Medicine.

The study, conducted by researchers at the University of Pittsburgh Graduate School of Public Health (GSPH) with collaborators at the Harvard School of Public Health and Vanderbilt University, suggests that calls for Congress to institute a longer moratorium on such advertising for new drugs would represent a dramatic departure from current practices.

The marketing of prescription drugs directly to patients, in addition to primary care or specialty physicians, has come under scrutiny in light of recent revelations about problems with adverse drug reactions that became apparent only after the drugs had been on the market and aggressively advertised for several years.

“Our analysis found that the trend toward increasing spending on direct-to-consumer advertising is likely to continue and efforts to enforce more stringent guidelines on such practices would require not only significant changes by the pharmaceutical industry but by the FDA as well,” explained Julie Donohue, PhD, assistant professor of in the Department of Health Policy and Management, GSPH.

Two influential agencies calling for increased Food and Drug Administration (FDA) oversight of direct-to-consumer advertising are the Institute of Medicine, an arm of the National Academy of Sciences, and the U.S. Government Accountability Office; both have found that the FDA’s enforcement of regulations governing direct-to-consumer advertising is inadequate. Legislation has been proposed in both the U.S. Senate and the House of Representatives that would give the FDA the power to screen all drug advertisements before they air and to place a moratorium on ads for a particular drug for several years after it has been approved.

Donohue and colleagues analyzed industrywide spending by pharmaceutical companies on direct-to-consumer advertising and promotions to physicians over the past decade. They also tapped into industry data to analyze which drugs were being advertised and to whom, as well as the timing of such advertising campaigns. Finally, they examined the number of FDA enforcement actions directed at such promotions from 1997 to 2006.

Their analysis found that the pharmaceutical industry’s total real spending on drug promotions almost tripled – from just over $11.4 billion to almost $30 billion — between 1996 and 2005.

They also found that the overwhelming majority of drug advertising was targeted to physicians. However, over the past nine years, spending on direct-to-consumer advertising and free samples has risen as a share of the total promotion budget, whereas promotional investment in professional journals fell. Real spending on direct-to-consumer advertising increased by 330 percent from 1996 to 2005 and made up 14 percent of total promotional expenditures in 2005 compared to less than 9 percent in 1996.

Spending on direct-to-consumer advertising was concentrated among a relatively small number of brands. The 20 drugs with the highest spending made up more than half (54.4 percent) of total industry spending on advertising in 2005. Most of these drugs were predominantly new drugs used to treat chronic conditions; 10 of the top 20 drugs, as ranked by advertising spending, were introduced in 2000 or later. Notably, nearly all (17 of 20) advertising campaigns for the most heavily advertised drugs began within a year of receiving FDA approval.

According to Meredith B. Rosenthal, Ph.D., associate professor of health economics and policy, Harvard School of Public Health, “The apparent decline in FDA enforcement of direct-to-consumer drug advertising regulations calls into question the FDA’s ability to prevent misleading messages about drug risks and benefits from reaching the public and heightens concerns about the potential adverse consequences such advertising might engender,” she said.

This study was supported by a grant to Donohue from the National Center for Research Resources, a component of the National Institutes of Health; NIH Roadmap for Medical Research; and the Alfred P. Sloan Foundation to Rosenthal. Donohue reports receiving consulting fees from GlaxoSmithKline and CanWest Global Communications.